Brazil sets a 0.3% THC cap for cultivation under RDC 1.013, but cannabis above 0.2% THC is classified as a List A3 controlled substance under RDC 1.011. Two thresholds, two purposes, one regulatory trap.
Why Does Brazil Have Two Different THC Limits for Cannabis?
Brazil’s 2026 cannabis framework introduced a quirk that catches even experienced operators: cultivation is permitted at THC at or below 0.3% by dry weight under RDC 1.013/2026, but the same Cannabis sativa L. plant is classified as a List A3 controlled substance once THC exceeds 0.2% under RDC 1.011/2026. An operator can be 100% compliant with the cultivation cap and still produce material that triggers the stricter dispensation, prescription, and accountability rules attached to List A3 under Portaria SVS/MS nº 344/1998.
The 0.3% cap is a cultivation production threshold: what you are allowed to grow on Brazilian soil for medicinal and research purposes. The 0.2% cutoff is a controlled-substance schedule boundary: how the resulting drug substance is handled downstream. Confusing the two is the single most common point of friction in early AE applications. This guide separates them, quotes the article text directly, and shows operators in the 0.2-0.3% gap exactly which obligations attach.
The 0.3% Cultivation Cap Under RDC 1.013 Art. 1: What It Covers
Article 1 of RDC 1.013/2026 sets the cultivation ceiling in plain language. The verbatim Portuguese text reads:
“Parágrafo único. O teor de 0,3% (três décimos por cento) se refere ao percentual total de THC presente, expresso em peso por peso (p/p) nas inflorescências secas.” RDC 1.013/2026, Art. 1, caput + sole paragraph. Source: DOU Nº 23, 03/02/2026, Seção 1, p. 194.
Three details inside that single article shape every AE application:
- Total THC, not delta-9 THC. The sole paragraph specifies percentual total de THC presente. Brazil measures total THC, which in practice means delta-9-THC plus the THC that would be released when THCA decarboxylates. This is the same approach Health Canada uses, and a deliberate contrast with the U.S. 2018 Farm Bill, which measures delta-9-THC only.
- Weight by weight (p/p) on dried inflorescences. The measurement is taken on the dried flowering tops, not whole-plant biomass. Operators must specify dry-weight inflorescence as the sample matrix; a whole-plant homogenate will produce a different number and will not match the regulatory threshold.
- Medicinal and research purposes only. Industrial hemp for fibre or grain is governed by a separate MAPA regime and is not the subject of RDC 1.013.
The consequence of exceeding 0.3% is direct. Article 18 of RDC 1.013 requires destruction of any plant material above the cap with 48-hour ANVISA notification. There is no remediation path; the cultivation AE itself can be suspended if non-conformances recur, with sanctions referenced to Lei 6.437/1977 under Article 29. Every cultivar in the production plan must be validated to consistently express total THC at or below 0.3% under the operator’s actual cultivation conditions, evidenced upfront by the propagation-material origin documentation in Article 4 and on every harvest by the per-lot lab analysis in Article 16.
The 0.2% Scheduling Boundary Under RDC 1.011: List A3 vs List B1 Explained
RDC 1.011/2026, published the same day as RDC 1.013, updates how Cannabis sativa L. is scheduled under Portaria SVS/MS nº 344/1998, the foundational Brazilian controlled-substances regulation. The scheduling cutoff sits at 0.2% total THC, not 0.3%, and it determines which prescription form, dispensation channel, and accountability regime applies.
| THC content (dry weight) | Portaria 344 list | Class | Prescription / receipt | Operator obligations |
|---|---|---|---|---|
| Above 0.2% | List A3 | Entorpecente (narcotic) | Notificação de receita A, yellow receipt; valid 30 days; one prescription per receipt | Stricter inventory accountability, segregated storage, controlled-substance transport rules, monthly balances under Portaria 344 |
| At or below 0.2% | List B1 | Psicotrópico (psychotropic) | Notificação de receita B, blue receipt; valid 30 days within the issuing state | Lighter inventory accountability than A3 but still controlled-substance accounting; balances and audit trail required |
The two frameworks measure the same molecule on the same plant, but answer different questions. RDC 1.013 answers “Can I grow it?” RDC 1.011 plus Portaria 344 answer “How tightly is the resulting drug substance controlled?” An operator with a single cultivar at 0.25% total THC is in dual compliance territory: the crop is legal to grow, and the dried inflorescences are List A3, dispensed against yellow notificação de receita A and inventoried under A3 accountability rules. Two sequential regulatory checks, both must pass.
How Do These Two Limits Compare to Hemp Rules in the U.S., Canada, and the E.U.?
Brazil’s two-threshold system is unusual. Most jurisdictions use a single number to draw the line between cannabis and hemp, then attach controlled-substance handling to the cannabis side. The Brazilian split means that the threshold for legal cultivation and the threshold for controlled-substance classification do not coincide.
| Jurisdiction | Legal basis | Threshold | What the number does | Measurement |
|---|---|---|---|---|
| Brazil, cultivation | RDC 1.013/2026, Art. 1 | At or below 0.3% total THC | Cultivation production cap for medicinal cannabis | Total THC, p/p, dried inflorescences |
| Brazil, scheduling | RDC 1.011/2026 + Portaria 344/1998 | 0.2% total THC boundary | Splits cannabis between List A3 (above) and List B1 (at or below) for controlled-substance handling | Total THC, p/p |
| United States, hemp | 2018 Farm Bill (7 U.S.C. § 1639o) | Not more than 0.3% delta-9 THC | Defines “hemp” vs Schedule I marijuana under the Controlled Substances Act | Delta-9 THC only, dry weight (no THCA included) |
| Canada, hemp | Industrial Hemp Regulations under the Cannabis Act | 0.3% total THC or less in flowering heads and leaves | Defines industrial hemp; commercial cannabis is everything above | Total THC (includes THCA conversion) |
| European Union, hemp | Regulation (EU) 2021/2115, Art. 4 (CAP) | 0.3% delta-9 THC (raised from 0.2% in 2023) | Defines eligible industrial-hemp varieties for CAP subsidies; member-state cannabis laws apply separately | Delta-9 THC on flowering or fruiting tops, EU-prescribed method |
Two contrasts matter for operators moving between markets. First, identical numbers can mean different things: the 0.3% in Brazil is total THC, the 0.3% in the U.S. Farm Bill is delta-9 only. A cultivar that passes the U.S. hemp test may fail Brazilian RDC 1.013 if the THCA content is meaningful. Second, Brazil’s split between the cultivation cap and the scheduling boundary has no direct international counterpart. Germany, Israel, Australia, and Colombia all treat anything above their hemp/medicinal line as controlled. Brazil’s choice to keep 0.2-0.3% material legally cultivated but List A3 scheduled is deliberate alignment with the 1961 UN Single Convention on Narcotic Drugs, which uses 0.2% as the cannabis carve-out for industrial use.
What Operators Caught in the 0.2-0.3% Gap Need to Know
The 0.2-0.3% range is the practical risk zone. Brazilian propagation material certified for medicinal cultivation sits in this range by design; breeders work upward from CBD-dominant or balanced chemovars toward the legal ceiling to maximise medicinal value. If your harvested droga vegetal consistently lands between 0.2% and 0.3% total THC, the following compliance stack applies in parallel.
Cultivation side: stay compliant with RDC 1.013
- Per-batch THC analysis under Article 16 of RDC 1.013, recorded against lot number.
- Lot-level traceability under Article 15: lot number, cultivation stage, start date, variety, and plant count for every lot.
- Destruction protocol under Article 18 for any batch that exceeds 0.3%, with 48-hour ANVISA notification.
- Quarterly and annual Balanço de Substâncias Psicoativas e Outras (BSPO) reports under Article 19.
Downstream side: handle the material as List A3 under Portaria 344
- Dispensed only against notificação de receita A (yellow receipt), valid 30 days, one prescription per receipt.
- Segregated, secured storage with restricted access; controlled-substance inventory controls.
- Controlled-substance transport under Article 22 of RDC 1.013, with tamper-evident numbered seals (Article 23) and labels carrying the lot number (Article 24).
- Monthly Portaria 344 balances filed by the receiving manufacturer or pharmacy, cross-referenced to the cultivation BSPO.
The hidden cost most operators underestimate: documentation and accountability is set by the downstream classification, not the cultivation cap. A 0.25% total THC harvest is grown like medicinal cannabis but handled like a narcotic. AE applicants should price in List A3 transport, storage, and dispensation logistics from day one, not assume the lower-control B1 regime applies.
Lab Testing Strategy: How to Hit Both Thresholds Without Material Loss
A defensible THC testing program for Brazilian cultivation has to answer two questions on the same sample: is the lot under the 0.3% cultivation cap (RDC 1.013 Art. 16), and which side of the 0.2% scheduling boundary does it fall on (RDC 1.011)? The recommended approach for AE-stage operators is straightforward:
- Pre-harvest screen. Sample inflorescences at peak maturity and test in-house with HPLC for total THC. If the screen approaches 0.28% or above, plan for an early harvest. Article 18 destruction is irreversible; an in-house screen at 0.32% costs hours, the same screen as a release test costs the whole lot.
- Lot-defined release test. Send a representative sample of dried inflorescences to an ANVISA-acceptable laboratory for the per-lot Article 16 release test. Specify total THC, p/p, on dried inflorescences as the matrix. HPLC-DAD with decarboxylation correction (or LC-MS/MS) covers both the cultivation cap and the scheduling boundary on one report.
- Report against both thresholds. Build the certificate of analysis to flag the result against 0.3% (cultivation) and 0.2% (scheduling), so the lot record carries one number that drives two regulatory paths.
- Bind the lab number to the Article 15 lot record. Every per-lot THC analysis under Article 16 needs to attach to the Article 15 lot identifier so an ANVISA inspection can trace a single batch from cultivation stage, through analysis, into BSPO balance, transport seal, and dispensing pharmacy.
Operators planning a chemovar portfolio for Brazil should also model the scheduling boundary into cultivar selection. A cultivar landing at 0.18% total THC stays in List B1 with lighter dispensation rules and may suit pharmacy-supply partners with limited A3 handling capability. A cultivar at 0.25% maximises medicinal cannabinoid yield but commits the whole supply chain to A3 handling. The cultivar decision now drives the prescription-receipt colour two years downstream.
Frequently Asked Questions
Can I sell cannabis with 0.3% THC as List B1 in Brazil?
No. The 0.2% boundary under RDC 1.011 is independent of the 0.3% cultivation cap under RDC 1.013. If your droga vegetal tests above 0.2% total THC, it is List A3 under Portaria 344/1998 regardless of how cleanly you complied with the cultivation rules. The yellow notificação de receita A applies, and the stricter A3 inventory, transport, and dispensation rules attach. Operators sometimes assume that legal cultivation up to 0.3% implies legal lighter-class dispensation up to 0.3%; it does not.
What happens if my batch tests at 0.31% THC?
The batch is a cultivation non-conformance under RDC 1.013. Article 18 requires destruction of plant material above the 0.3% cap with notification to ANVISA within 48 hours. The resolution provides no remediation path; the batch cannot be re-blended down or sold for any medicinal use. Repeated non-conformances expose the establishment to AE suspension and sanctions under Lei 6.437/1977 as referenced in Article 29. Pre-harvest screening at peak maturity is the single most effective control against this loss.
Is the 0.3% measured the same way as in the U.S. hemp definition?
No. The U.S. 2018 Farm Bill measures delta-9 THC only on a dry-weight basis, with THCA not included in the calculation. Brazil’s RDC 1.013 Article 1 specifies “percentual total de THC”, total THC, expressed in p/p on dried inflorescences. Total THC accounts for the conversion of THCA to delta-9 THC under decarboxylation, so a cultivar that passes the U.S. hemp test may fail the Brazilian cultivation cap if the THCA content is meaningful. Canada and the EU also measure total THC, so Brazilian operators sourcing propagation material should treat U.S. hemp-genetics certifications as informative but not equivalent.
Can I grow cannabis below 0.2% THC in Brazil?
Yes. RDC 1.013 caps cultivation at 0.3% total THC; a cultivar that consistently expresses 0.15% total THC is well under the cultivation ceiling. The resulting droga vegetal falls into List B1 under RDC 1.011 (blue notificação de receita B) rather than List A3, which simplifies pharmacy-supply partnerships and lowers controlled-substance accountability cost. A B1-targeted chemovar strategy makes commercial sense for CBD-dominant medicinal products, but operators must still hold a full RDC 1.013 cultivation AE; the cultivation regime is the same whether the harvest lands in B1 or A3.
How is THC measured at the lab under RDC 1.013 Article 16?
Article 16 requires per-lot laboratory analysis of THC content in the droga vegetal obtained from cultivation but does not prescribe a specific instrumental method. The de-facto standard for Brazilian medicinal cannabis is HPLC (DAD or UV) with decarboxylation correction or LC-MS/MS, performed on a representative sample of dried inflorescences, with results reported as percentage by weight (p/p) total THC. The lab itself must be acceptable to ANVISA. Build the certificate of analysis to report the result against both the 0.3% RDC 1.013 cultivation cap and the 0.2% RDC 1.011 scheduling boundary, and bind the result to the Article 15 lot record.
One Lot Number, Two Thresholds, Zero Spreadsheets.
Binds Article 15 lot IDs to Article 16 THC results, flags the 0.2% scheduling boundary at the certificate of analysis, and carries Portaria 344 handling automatically. One export covers both thresholds.
REQUEST DEMO
Recommended For You
HighIQ Webinar Series: Powering Precision Production with Total Grow Control
May 8, 2026Portugal’s Cannabis Exports Triple: 42 Tonnes to Germany and Growing as Europe’s Processing Hub
April 22, 2026UK Medical Cannabis Prescriptions Surge 262%: 80,000 Patients and a GBP 500M Private Market
April 21, 2026About GrowerIQ
GrowerIQ is changing the way producers use software - transforming a regulatory requirement into a robust platform to learn, analyze, and improve performance.
To find out more about GrowerIQ and how we can help, fill out the form to the right, start a chat, or contact us.